Surgical device for injecting cement into a bone cavity

ABSTRACT

A surgical device and method for injecting cement in a bone cavity includes an elongated, hollow body to be inserted partially into the cavity. The body has an inner lumen with a distal opening to expel cement therefrom. An entry plug for the cement is connected to a cement pressurized supply. The entry plug is in fluid communication with the lumen to deliver cement through the entry plug, wherein the entry plug is movably mounted on the hollow body.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of application Ser. No. 12/756,637 filed Apr. 8,2010, which claims the benefit of U.S. Provisional Application Ser. No.61/168,295, filed Apr. 10, 2009, both disclosures of which areincorporated by reference herein in their entireties.

BACKGROUND

1. Technical Field

The present invention relates to surgical devices and more particularlyto a surgical device for injecting cement in a bone cavity.

2. Description of the Related Art in surgery, particularly inosteoplasty or vertebropiasty, cement delivery devices are known whichare adapted to allow an operator to inject viscous cement inside thevertebral body. These devices, hereby referred to as an example, providecontrol over the exact deposit location and directionality of cementdelivery by means of a curvable, distal delivery needle, which allowsnavigation within the vertebral body. As a result of the needle design,the operator at all times has control over the curvature and directionof the delivery needle, providing direct access to the entire vertebralbody, which allows for patient specific customization of cement deliveryduring the procedure.

A main drawback of such devices stems from the necessity for theoperator to rotate the needle inside the vertebral body in order tospread the cement uniformly therein. In fact, the needle is able to bendonly moving inside a plane (like the movement of a finger). Therefore,to direct the injected cement in all directions the needle must berotated.

Since the cement is supplied to the needle through a pipe connectedfixedly to the same needle, usually at a right angle, the operator mustchange position around the patient to rotate the needle. In a surgeryroom, filled with machines and operating personnel, this may beunpractical, awkward or even impossible.

SUMMARY

In useful embodiments, surgical operation of the foregoing type is easedby allowing a greater freedom of movement to a surgeon. This may beachieved by a surgical device for injecting cement in a bone cavity,comprising an elongated, hollow body to be inserted partially into thecavity; the body having an inner lumen with a distal opening to expelcement therefrom; an entry plug for the cement from a cement pressurizedsupply the entry plug being in fluid communication with the lumen todeliver cement through it, wherein the entry plug is mounted movably onthe hollow body.

The mobile disposition of the plug on the hollow body, whether it has aninner lumen with only an outlet for the cement or with another oppositeinlet from which the inside of the bone may be reached, allows the plugor a connector for the cement from the device to be free, making it muchmore handy and efficient. The pipe conveying cement to the device mayarticulate and/or have a joint on it, thereby eliminating the drawbacksdescribed. Advantageous variants of the invention are also provided.

A surgical device and method for injecting cement in a bone cavityincludes an elongated, hollow body to be inserted partially into thecavity. The body has an inner lumen with a distal opening to expelcement therefrom. An entry plug for the cement is connected to a cementpressurized supply. The entry plug is in fluid communication with thelumen to deliver cement through the entry plug, wherein the entry plugis movably mounted on the hollow body.

These and other features and advantages will become apparent from thefollowing detailed description of illustrative embodiments thereof,which is to be read in connection with the accompanying drawings.

BRIEF DESCRIPTION OF DRAWINGS

The advantages of the invention will be clearer from the followingdescription of embodiments thereof, with the attached drawings wherein:

FIG. 1 shows a cross sectional view of a first variant of the invention;

FIG. 2 shows a cross sectional view of a second variant of theinvention;

FIG. 3 shows a cross sectional view of a third variant of the invention;

FIG. 4 shows a cross sectional view of a fourth variant of theinvention;

FIG. 5 shows a cross sectional view of a fifth variant of the invention;

FIG. 6 shows a cross sectional view of a detail in FIG. 5; and

FIG. 7 shows a cross sectional view of a variant for the detail in FIG.6.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

A surgical device for injecting cement in a bone cavity is provided. Inone embodiment, the device includes an elongated, hollow body to beinserted partially into the bone cavity. The body includes an innerlumen with a distal opening to expel cement therefrom, and an entry plugfor the cement from a cement pressurized supply. The entry plug is influid communication with the lumen to deliver cement through it, whereinthe entry plug is mounted movably on the hollow body. The mobiledisposition of the plug on the hollow body, whether it has an innerlumen with only an outlet for the cement or with another opposite inletfrom which the inside of the bone may be reached, allows the plug or aconnector for the cement from the device to be free, making it much morehandy and efficient. The pipe conveying cement to the device mayarticulate and/or have a joint on it for flexible operation.

Referring now to the drawings in which like numerals represent the sameor similar elements and initially to FIG. 1, a first device according tothe invention is indicated at 10 and comprises a tubular body 12elongated along a longitudinal axis X. The body 12 has a coaxial innerchannel 22 with an inlet 22 a and an outlet 22 b. The channel 22communicates radially (along an axis Y orthogonal to axis X, see angleα) with two orthogonal channels 24 opening into an annular recessedportion 26. The recessed portion 26 is obtained in a thicker region 28of the body 12, wherein the region 28 forms a circular step 30 with theremaining part of the body 12. The body 12 in this example may be asteerable needle to inject cement in a bone.

An annular member 40 is arranged around the body 12 and has a radial,pass-through channel 42 terminating externally with a funnel-shapedconnector 44. The channel 42 opens into an annular, inner recessedportion 46 arranged over and matching in width the recessed portion 26.The innermost radius of the member 40 matches very precisely theoutermost radius of the region 28 to have a good fitting. Twofluid-tight ring gaskets 50 are arranged between the annular member 40and the body 12 into proper recessed seats. The gaskets 50 are placed atthe borders of the region 28, opposite to the portion 26.

Two calotte-shaped covers 60 a, 60 b are attached, e.g. by means ofultrasonic welding, to the sides of the annular member 40, so as toenclose the gaskets 50 therebetween and to abut against a step 30. Inthis manner the covers 60 a, 60 b retain the member 40 in a fixedposition with respect to the axis X over the body 12. The annular member40 and the covers 60 a, 60 b result in being integral with each otherand are able to be rotated on the body 12 about the axis X in afluid-tight manner, but without asking for an excessive driving torque.These two elements slide over the gaskets 50. Also, it is to be notedthat the device 10 is symmetric with respect to axes X and Y.

During surgery operations, the inlet 22 a is used to control a wire (notshown) running inside the channel 22 up to the body 12's tip (notshown), where it can pull the end thereof to bend it. The connector 44is connected by a pipe to a pump supplying cement. The cement enters theconnector 44, runs into the channels 24 and invades the regions 26, 46,from which it goes on inside the channel 22 towards the outlet 22 b tothe bone. Since the connection carrying the cement is not fixed to, butcan rotate on, the body 12 thanks to the rotation of the member 40, itis apparent that the available movements of a surgeon are greatlyimproved. The body 12 can be rotated about the axis X (see arrow R1),e.g. to better distribute the cement inside a vertebra, without theconstraint of moving the cement supplying pipe. Instead, the member 40rotates around the body 12 and leaves the cement entry point in a quiteconstant position.

FIG. 2 relates to a variant of the device, indicated by 100. The secondvariant comprises a tubular, tapered body 112 elongated along alongitudinal axis Y1. The body 112 has a coaxial inner channel 122 witha funnel-shaped inlet 122 a and an outlet 122 b. The channel 122communicates radially (along an axis X1 orthogonal to axis Y1, see angleα1) with one or more channels 124 opening in the lateral surface 126 ofthe body 112.

An annular member 140 is arranged around the body 112 and has a radial,pass-through channel 142 terminating externally with a funnel-shapedconnector 144 fixed thereto. The channel 142 opens into an annular,inner recessed portion 146 of the member 140. The innermost radius ofthe member 140 matches very precisely the outermost radius of the body112, to have a good fitting. Two fluid-tight ring gaskets 150 arearranged between the annular member 140 and the body 112 into properrecessed seats. The gaskets 150 are placed at a distance from, andbeside, the portion 146 and the channel 142.

Two calotte-shaped covers 60 a, 60 b are attached, e.g., by means ofultrasonic welding, to the sides of the annular member 140, so as toenclose the gaskets 150 therebetween and to abut against a step 130. Inthis manner the covers 160 a, 160 b retain the member 140 in a fixedposition with respect to the axis Y1 over the body 112.

The annular member 140 and the covers 160 a, 160 b result in beingintegral with each other and are able to be easily rotated on the body112 about the axis Y1 in a fluid-tight manner. These two elements slideover the gaskets 150. It is to be noted that the device 100 is symmetricwith respect to axes X1 and Y1.

During surgery operations, the operation of the device 100 is analogousto that of device 10 as to the free rotation of the member 140 on thebody 112, thereby allowing the movement of the cement entry point on thebody 112 (see arrow R2). The difference in this variant is that theinlet 122 a may be used to insert in a bone cavity to be cemented to anIR antenna to kill cancer, a micro-camera or any other device able toexplore, or operate inside, such bone cavity.

FIG. 3 shows a third variant, indicated by 200; the central part beingidentical to the device 100, thus it will be described briefly. Thethird variant comprises a tubular body 212, elongated along alongitudinal axis Y3, having a coaxial inner channel 222. The channel222 communicates radially with one or more channels 224 opening in thelateral surface thereof.

An annular member 240, analogous to member 140, is arranged around thebody 212. The member 240 houses inside, in a spherical cavity, aspherical termination 245 of a connector 244. The connector 244 ishollow and exhibits an inner channel 242 opening both outwards andtoward the spherical termination 245, which has an opening 247communicating with the channel 224. As before, two fluid-tight ringgaskets 250 are arranged between the annular member 240 and the body212, thereby promoting the rotatable coupling thereof.

Two calotte-shaped covers 260 a, 260 b are attached to the sides of theannular member 240, so as to enclose the gaskets 150 therebetween. Theannular member 240 is able to be easily rotated on the body 212 aboutthe axis Y3 in a fluid-tight manner (see arrow R3). Also, the connector244 can be oriented with respect to the member 240 gaining an additionaldegree of freedom (see arrow F3).

During surgery operations, the operation of the device 200 is analogousto that of device 100, with the benefit that the pipe carrying cement,to be connected to the connector 244, has also an articulated connectionon the member 240, and hence the device 200 is more maneuverable.

Another variant 300 of the device is shown in FIG. 4. This variantcomprises a tubular body 312 elongated along a longitudinal axis Y4. Thebody 312 has a coaxial inner channel 322 communicating radially with oneor more channels 324 opening toward a spherical cavity 347 of aspherical termination 345 belonging to a connector 344. The connector344 is hollow and exhibits an inner channel 342 opening both outwardsand toward the spherical termination 345, which, through the opening347, makes the channel 324 communicate with the mouth of the connector344.

Thanks to its spherical termination 345 the connector 344 can beoriented jointly with respect to the body 312 gaining an additionaldegree of freedom (see arrow F4) for the connector 344. Thus, duringsurgery operations, the device 300 has the benefit that the pipecarrying cement has also an articulated connection on the body 312. Evenif with minor amount with respect to the previous one, the device 300 ismore maneuverable than the known devices.

Another device according to the invention is shown at 400 in FIG. 5 andcomprises a tubular body 412 elongated along a longitudinal axis X5, inone example, a needle for injecting cement. The needle 412 has acoaxial, inner channel 422 with an outlet 422 a. The channel 422communicates radially (along an axis Y5 orthogonal to axis X5) with twoorthogonal channels 424 opening into an annular recessed portion 426.The recessed portion 426 can be obtained by milling the needle 412.

An annular member 440 is arranged around the body 412 and has afunnel-shaped external connector 444 whose tip projects internally fromthe inner wall of the member 440. The innermost radius of the member 440matches very precisely the outermost radius of the needle 412, in orderto have a good fitting. Two fluid-tight ring gaskets 450 are arrangedbetween the annular member 440 and the needle 412 into proper recessedseats. The member 440 can rotate about the axis X5 on the needle 412 andcan also slide thereon for a distance longitudinally along the axis X5.This is because the tip of the connector 444 can move between the wallsof the annular recessed portion 426 without coming out therefrom,sliding on the gaskets 450.

During surgery operations, the left part (in the drawing) of the needle412 with respect to the member 440 can be used to control or handle theneedle 412. The operation of the device 400 is analogous to that ofdevice 100 as to the free rotation of the member 440 on the needle 412,thereby allowing in such a manner the movement of the entry plug for thecement on the needle 412 (see arrow R5).

FIGS. 6 and 7 show two different methods for fixing the connector 444 tothe member 440. This holds also for the preceding and other variants. InFIG. 6 the connector 444 exhibits on a stem 447 thereof, a terminalthread 480 to be threaded on a corresponding thread in the member 440.On the stem 447, in a more external position, there is obtained acircular seat to house a fluid-tight gasket 470 into it.

In FIG. 7 the connector 444 still exhibits on a stem 447 thereof, aterminal thread 480 to be threaded on a corresponding thread in themember 440. On the stem 447, in a more external position and flush tothe surface of the member 440, there is obtained an undercut 479.Between the undercut 479 and a circular-plan step 474 obtained on thesurface of the member 440 there is housed a fluid-tight gasket 472.

Essentially, with respect to FIG. 6 the way the gasket 470 is integratedin the device is modified. Generally speaking, the covers 60 a, 60 b or160 a, 160 b or 260 a, 260 b may also be fixed by screwing to a threadportion in the member 40, 140, 240 or by gluing. Suitable materials forsuch covers include, e.g., polycarbonate or nylon. The gaskets 50, 150,250, 450, 470, 472 may be of different type, e.g., o-rings orlip-gaskets.

In FIGS. 1, 2 and 5 the axes X, Y and X1, Y1 and X5, Y5 are described asperpendicular, but the orientation of the connector 44, 144, 444 and/orthe channel 42, 142, 442 relative to the respective channel 22, 122, 422may be different, e.g., forming acute angles α, α1, and not only of 90degrees.

Having described preferred embodiments of a device and methods for itsuse (which are intended to be illustrative and not limiting), it isnoted that modifications and variations can be made by persons skilledin the art in light of the above teachings. It is therefore to beunderstood that changes may be made in the particular embodimentsdisclosed which are within the scope of the invention as outlined by theappended claims. Having thus described aspects of the invention, withthe details and particularity required by the patent laws, what isclaimed and desired protected by Letters Patent is set forth in theappended claims.

What is claimed is:
 1. A surgical device injecting bone cement in a bone cavity, comprising: an elongated, hollow body having an inner lumen with a distal opening to expel bone cement therefrom, and including a thicker region having at least two recessed seats; a movable member having access to the bone cement from a bone cement pressurized supply, the movable member being in fluid communication with the lumen to deliver bone cement through the hollow body, wherein the movable member is rotatably mounted to and forms a fluid-tight seal with a surface of the hollow body; and at least two gaskets disposed in and filling the recessed seats of the thicker region, wherein an innermost radius of the movable member matches an outermost radius of the elongate body to form the fluid-tight seal enabling the movable member to rotate about a longitudinal axis of the body.
 2. The device of claim 1, wherein the member includes a connector having a tip projecting internally into an inner wall of the movable member.
 3. The device of claim 2, wherein the body includes an annular recessed portion and wherein the tip projects into said annular recessed portion.
 4. A surgical device injecting bone cement in a bone cavity, comprising: an elongated, hollow body having an inner lumen with a distal opening to expel bone cement therefrom; a member having access to the cement from a bone cement pressurized supply, the member being in fluid communication with the lumen to deliver bone cement through the hollow body, wherein the member is movably mounted on the hollow body; and further comprising two cover elements integral with the member and placed on opposite sides thereof, the cover elements abutting on at least one annular step formed on a lateral outer surface of the body.
 5. The device according to claim 4, wherein the body further comprises an opening for gaining access to the cavity through the lumen and located opposite from the distal opening.
 6. The device according to claim 4, wherein the member comprises a rotatable member rotatably mounted around the lateral surface of the body, the rotatable member being provided with a connector for a pipe for the bone cement and with at least one pass-through, radial channel allowing bone cement fluid communication with the lumen of the body.
 7. The device according to claim 6, wherein the body comprises at least one radial channel connecting its lateral surface to the lumen and located so as to receive the bone cement coming from a pass-through, radial channel of the rotatable member.
 8. The device according to claim 7, wherein the at least one radial channel of the body and the at least one pass-through, radial channel of the rotatable member have parallel axes.
 9. The device according to claim 6, wherein the rotatable member has an annular, recessed portion at an outlet of the at least one pass-through, radial channel, said portion facing the lateral surface of the body.
 10. The device according to claim 7, wherein the body in its lateral surface has an annular, recessed portion at the outlet of the at least one radial channel.
 11. The device according to claim 4, wherein the member is mounted through a joint on the body and with respect to the body.
 12. The device according to claim 6, wherein the connector is mounted through a joint on the rotatable member.
 13. The device according to claim 6, wherein the connector is fixed in the rotatable member through a coupling of a threaded portion thereof.
 14. The device according to claim 13, wherein at the threaded portion there is mounted a gasket placed between the connector and the rotatable member.
 15. The device according to claim 14, wherein the gasket placed between the connector and the rotatable member is housed in a peripheral groove on said connector.
 16. The device according to claim 14, wherein the gasket placed between the connector and the rotatable member is placed between a peripheral undercut on said connector and a circular-plan step on said rotatable member.
 17. The device according to claim 2, wherein the tip of the connector projects internally from the rotatable member and is slidingly confined between side walls of a groove on the lateral surface of the body.
 18. A surgical device injecting bone cement in a bone cavity, comprising: an elongated, hollow body having an inner lumen with a distal opening to expel bone cement therefrom; a member having access to the cement from a bone cement pressurized supply, the member being in fluid communication with the lumen to deliver bone cement through the hollow body, wherein the member is movably and rotatably mounted on the hollow body, and wherein the body has a part opposite to the distal opening with respect to the member for controlling or handling the body.
 19. The device according to claim 18, wherein the tubular body is a needle for injecting cement.
 20. The device according to claim 18, wherein the member comprises a rotatable member rotatably mounted around the lateral surface of the body, the rotatable member being provided with a connector for a pipe for the bone cement and with at least one pass-through, radial channel allowing bone cement fluid communication with the lumen of the body.
 21. The device according to claim 20, wherein the body comprises at least one radial channel connecting its lateral surface to the lumen and located so as to receive the bone cement coming from a pass-through, radial channel of the rotatable member.
 22. The device according to claim 21, wherein the at least one radial channel of the body and the at least one pass-through, radial channel of the rotatable member have parallel axes.
 23. The device according to claim 18, wherein an innermost radius of the movable member matches an outermost radius of the elongate body to form the fluid-tight seal enabling the movable member to rotate about a longitudinal axis of the body.
 24. The device according to claim 18, wherein the movable member forms a fluid-tight seal with a surface of the hollow body; and at least two gaskets are disposed between the member and the tubular body in recessed seats of the tubular body. 